← Product Code [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT) · K163552

# iPulse SmoothSkin BARE Hair Removal Device (K163552)

_Cyden Limited · OHT · Mar 3, 2017 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K163552

## Device Facts

- **Applicant:** Cyden Limited
- **Product Code:** [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT.md)
- **Decision Date:** Mar 3, 2017
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

The iPulse SmoothSkin BARE Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin BARE is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.

## Device Story

iPulse SmoothSkin Bare is an over-the-counter light-based hair removal device. It utilizes intense pulsed light (IPL) technology to target hair follicles, inhibiting regrowth. Designed for home use by consumers. Device emits light pulses to the skin surface; energy absorption by melanin in hair shaft leads to thermal damage of follicle. Regular treatment cycles required for permanent reduction. Benefits include long-term, stable reduction of hair regrowth.

## Clinical Evidence

No clinical data provided in the document.

## Technological Characteristics

Intense Pulsed Light (IPL) hair removal system. Over-the-counter device for home use. Operates via light-based energy emission for follicle targeting.

## Regulatory Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

## Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2017

Cyden Limited Mike Kiernan Chief Scientific Officer Technium 2, Kings Road Swansea, SA1 8PJ GB

Re: K163552

Trade/Device Name: Ipulse Smoothskin Bare Hair Removal Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT, GEX Dated: January 31, 2017 Received: February 2, 2017

Dear Mike Kiernan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163552

Device Name

iPulse SmoothSkin Bare Hair Removal System

Indications for Use (Describe)

The iPulse SmoothSkin BARE Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin BARE is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.

| Type of Use (Select one or both, as applicable) |  |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K163552](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K163552)

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